Study Stopped
Financial problem (not enough budget to continue the study)
Active Control of Prostatic Cancer With Criteria of Latence
SURACAP
2 other identifiers
observational
100
1 country
15
Brief Summary
This study concern a prospective cohort pf patients with latent prostate cancer. We study the specific survival at 10 years of patients who accept an active control.Patients inclusion are realized in 2 stages:
- patient with inclusion criteria (PSA \< 10 ng/ml, clinical stage T1c or T2a, Gleason \< or = 6) are registered if they accept a second prostate biopsy in a 3 months delay
- after analyse of second biopsy in central laboratory and confirmation of latent prostate biopsy, patients are included if they accept active control Included patients will have 1 biopsy by years the first two years and then 1 biopsy each 2 years during 8 years. If progression of cancer happens during the 10 years control, active control will be stopped and patient will be treated by surgery and chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2007
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 4, 2015
June 1, 2015
6 years
June 12, 2009
June 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluates specific survival to 10 years
10 years
Secondary Outcomes (6)
To evaluate acceptation of 2nd biopsy to confirm latent cancer
10 years
To evaluate global survival of patient in control
10 years
To evaluate the survival of patient with a secondary active treatment after a control period
10 years
To evaluate delay to secondary treatment after a period control
10 years
To evaluate survival rate without biological or clinical progression of cancer
10 years
- +1 more secondary outcomes
Study Arms (1)
control group
Patient with latent prostate cancer who agree to be controled instead of to be treated
Interventions
patient of control group will have : * 1 prostate biopsy 3 months after diagnostic biopsy * 1 prostate biopsy each year during 2 years * 1 prostate biopsy each 2 years during 8 years
Eligibility Criteria
patients with latent prostate cancer who agree to be controlled instead of to be immediately treated for this cancer
You may qualify if:
- patient with a latent prostatic cancer
- aged less 75 years old,
- life expectation higher than 10 years
- Clinic statue T1c or T2a
- with a seric PSA (prostatic specific antigen)smaller than 10ng/ml
- more than 10 biopsy cores samples
- patient with less than 3 cores samples with tumor and none care sample with more than 3mm of tumor
- Gleason score inferior at 7
- patient's agreement about project and a second biopsy which will include definitive patient: realized 3 months after the first and having: 14 biopsy cores samples (10 like previously and 4 more specific: taking around the positives initials biopsies), less than 3 cores samples with tumor, ,any cores samples with more than 3mm of tumor, a Gleason score superior at 7.
You may not qualify if:
- patient aged 75 years old and more
- no patient's agreement
- lack of understanding of plan
- patient with guardianship
- life expectation smaller than 10 years
- patient with an other cancer less than 5 years
- Local clinical statue greater than T2a
- seric PSA higher than 10ng/ml
- less than 10 biopsies
- more than 2 positives biopsies during the first intervention
- cores samples with more than 3mm of tumor
- th grade on the biopsies
- patient's refuse to realize the second biopsies
- patient who ask a treatment after the first medical examination
- patient with less 4 special biopsies around the previously initial cores samples or more than 2 positives biopsies or biopsies with more than 3mm of tumor or patient having a 4 grade on biopsies, during the second medical examination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
R Azzouzi
Angers, France
Jean-Louis DAVIN
Avignon, France
Henri BENSADOUN
Caen, 14000, France
SALOMON
Créteil, France
René GASCHIGNARD
La Roche-sur-Yon, 85000, France
RUFFION
Lyon, 69000, France
Eric LECHEVALLIER
Marseille, 13 385, France
P. ROSSI
Marseille, 13000, France
Xavier REBILLARD
Montpellier, France
RIGAUD Jérôme
Nantes, France
Christophe AVANCES
Nîmes, France
IRANI Jacques
Poitiers, 86000, France
P Colloby
Pontoise, France
Clinique Mutualiste Chirurgicale
Saint-Etienne, 42055, France
SOULIE Michel
Toulouse, 31059, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas MOTTET, Dr
Clinique Mutualiste Chirurgicale
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 16, 2009
Study Start
December 1, 2007
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 4, 2015
Record last verified: 2015-06